Trial Review

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Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures)

Eligible subjects manually assigned an allocation number in sequential order by blinded study staff. Treatment dispensed in a blinded fashion by an unblinded pharmacist based on an unblinded master treatment allocation schedule.

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Methods used to generate the sequence in which subjects will be randomised (sequence
generation)

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Masking / blinding

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Who is / are masked / blinded?

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Intervention assignment

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Other design features

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Phase

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Type of endpoint(s)

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Statistical methods / analysis

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Recruitment

Recruitment status

Stopped early

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Data analysis

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Reason for early stopping/withdrawal

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Date of first participant enrolment

Anticipated

1/11/2008

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Actual

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Date of last participant enrolment

Anticipated

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Actual

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Date of last data collection

Anticipated

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Actual

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Sample size

Target

40

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Accrual to date

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Final

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Recruitment in Australia

Recruitment state(s)

VIC

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Funding & Sponsors

Funding source category [1]40200

Commercial sector/Industry

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Name [1]40200

Schering-Plough

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Address [1]40200

2000 Galloping Hill RoadKenilworth, New Jersey 07033

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Country [1]40200

United States of America

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Primary sponsor type

Commercial sector/Industry

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Name

Schering-Plough

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Address

2000 Galloping Hill RoadKenilworth, New Jersey 07033

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Country

United States of America

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Secondary sponsor category [1]36130

None

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Name [1]36130

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Address [1]36130

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Country [1]36130

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Ethics approval

Ethics application status

Approved

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Ethics committee name [1]61010

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Ethics committee address [1]61010

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Ethics committee country [1]61010

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Date submitted for ethics approval [1]61010

22/09/2008

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Approval date [1]61010

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Ethics approval number [1]61010

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Summary

Brief summary

Experiments in animals and research data in humans strongly suggests that IL-17A is involved in the formation of joint inflammation in rheumatoid arthritis. The primary purpose of this study is to establish the safety of blocking the effects of IL-17A with SCH 900117 in healthy subjects and in patients with rheumatoid arthritis.